Clinical Research Associate Level II - ALLEN SPOLDEN : Job Details

Join our dynamic team as a Clinical Research Associate Level II, where you will play a vital role in supporting clinical trials and contributing to groundbreaking research. In this position, you will work closely with our clinical study team under the guidance of your supervisor or designee.

Key Responsibilities:

• Actively participate in the design and preparation of clinical study protocols and case report forms.
• Develop and generate clinical SOPs, policies, charters, and comprehensive plans that comply with both US and international guidelines.
• Evaluate potential clinical sites based on established criteria to ensure acceptability.
• Manage the procurement of budgets, contracts, regulatory documents, and other essential administrative materials associated with clinical research.
• Initiate studies by conducting site visits, organizing the shipment of clinical supplies, case report forms, and other necessary materials.
• Conduct thorough monitoring of ongoing studies through frequent site visits, ensuring adherence to protocols, and inspecting study files.
• Prepare detailed site visit reports that highlight key accomplishments, issues requiring resolution, and recommendations for follow-up actions.
• Conduct study termination visits, collect final reports from investigators, and contribute to the preparation of final reports for regulatory submission.
• Assist in the maintenance of clinical archives and electronic files.
• Perform additional tasks as assigned to support clinical research operations.

Qualifications:

• Bachelor's degree in a related field (BA, BS, RN, BSN) or equivalent experience.
• 1-2 years of experience in clinical research or a comparable training background.
• Basic understanding and adherence to Good Clinical Practices (GCP).
• Exceptional attention to detail and multi-tasking abilities.
• Uncompromising integrity and the highest ethical standards.
• Excellent written and verbal communication skills.
• Motivated, assertive, and driven individual who can work independently.

Benefits: Enjoy comprehensive benefits including Dental, Medical, Vision, and a 401K plan.

If you're passionate about making a difference in clinical research, we encourage you to apply!